Pharmaceutical company specializing on developing novel treatments for mental health conditions Small Pharma Inc. (CVE: DMT) (OTCQB: DMTTF) having been granted an innovation passport designation for SPL026 the lead product candidate for its DMT assisted therapy for treatment of major depressive disorder (MDD) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).
The Innovative Passport is an innovative medicine designation which gives access to the Innovative Licensing and Access Pathways (ILAC) which is responsible for speeding time to market and facilitating access to patient access to emerging and novel treatments.
The ILAC provides a single integrated platform for sustained collaborative efforts working among the MHRA, medical developers and its partners, this allows for enhanced monitoring and coordination of important product development activities.
Since Small Pharma is now under ILAC, this means that it will have access to toolkit to support all stages of design, development and approvals process and also identify major areas for future engagement.
“Similar to the FDA’s fast-track in the United States, the U.K.’s MHRA Innovation Passport provides us with access to specialist advice throughout the drug development process and has the potential to enable a speedier, more efficient development process for SPL026, the lead candidate in our psychedelic-assisted therapy approach for the treatment of MDD. SPL026 entered clinical trials at the beginning of 2021 and this designation marks an important step forward towards an accelerated drug approval pathway for bringing the benefits of SPL026 to market for patients suffering with MDD,” said the company’s CSO, Dr. Carol Routledge.